Johana V. Espinoza Email & Phone Number

Raleigh, Nc, Us

•Identify and organize resources and services needed to accomplish tasks, set objectives, plan for contingencies, and managing time effectively.•Oversee site-level study status, timelines; identify opportunities and recommend an implementation action plan for sites not meeting expectations•Resource for site managers, coordinators, and physicians to ensure adherence to the protocol and their site-level scope of work, in addition to regulatory compliance •Oversee site identification, qualification, start-up, conduct, and close-out•Compile and submit project level protocol amendments, in conjunction with supervising investigators, Project Leader, and Sponsor. •Responsible for project-level regulatory compliance with designated regulatory agencies, including the Smart IRB •Perform ongoing vendor management and reporting including issue resolution, accuracy, and timeliness of vendor. •Provide direct input and coordinate strategic planning, development, and conception of Electronic Data Capture (EDC) systems-IBM Clinical Development, Medidata RAVE, CTMS, and Microsoft Access databases (Model, PID, and Query). •Prepare and maintain monthly consolidation of site payment reports as set forth in the site level and project level contractual agreement.

Raleigh-Durham, North Carolina Area

• Recommend plans and oversee site start-up, from recruiting of sites to activation• Develop and provide descriptive as well as analytical feedback on a variety of reports, documents and study processes• Review internal study activities and provide leadership with recommendations on how to address detected deficiencies • Create and monitor a variety of reports and queries from Electronic Data Capture (EDC) systems, Clinical Trials Management System,(CTMS) and Microsoft Access• Participate in the development of protocols, Case Report Forms (CRF’s), queries, newsletters, projects specific Standards of Practice (SOP) and study related documents• Recommend and implement modifications to existing procedures. • Develop and implement internal study processes• Prepare and provide training to site level personnel, e.g. coordinators, Regulatory staff, and Principal Investigators• Oversee informed consent software updates and loading to iPad devices• Set ad hoc agenda items for routine meetings, report on action items and take & distribute meeting minutes • Review required elements for Informed Consent Forms, Medical Release Form, IRB applications, annual renewals, amendments, close-outs, waivers and other required regulatory documents. • Oversee access, upload documents and make updates to WordPress and SharePoint website• Create, distribute and ensure completion of Qualtrics surveys • Resource for questions from team members, project leadership and sponsors

Raleigh-Durham, North Carolina Area

• Procure data through interviews, analysis of records and other sources• Assist in training new project personnel• Management of research site activities-including: regulatory compliance, data collection, and monitoring. • Maintain and update EDC access • Update and generate weekly reports from database• To facilitate translation and back translation of all necessary documents, as appropriate for local Spanish speaking country requirements• Identify and report site compliance issues• Provide input on database creation to ensure study needs are met

Raleigh-Durham, North Carolina Area

• Provide account services to customers by cashing checks and selling cashier’s checks• Record transactions and other special services to prepare currency transaction reports• Maintain customer confidence and protect bank operations by keeping information confidential• Accept cash deliveries and make deposits to store accounts• Schedule, supervise and train recently hired tellers • Approve/oversee transactions as needed, assist with balancing issues and verification of cash outages

Business Administration

Activities and Societies: Attended as a full time student while working full time.I assisted as one of the coordinators for the Youth Fair.

High School Diploma

Bachelor Of Business Administration - Bba